Product description:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Material: 100% cotton or 50% polyester - 50% cotton.
Reusable woven fabrics:
Fabric: 100% cotton.
- Weight per m²: 196 g/m²
- Number of threads per 3 cm: Warp: 75; Weft: 75
- Metric count: Warp: 28 / Weft: 27
or
Fabric: cretonne, cotton 100%:
- Number of threads/cm: warp: 24, weft: 24
- Metric count: warp: 28, weft: 28
- Weight per m²: 180g
or
Fabric : 50%polyesther-50% cotton fabric
- Weight per m²: +/- 175gr/m²
- Number of threads: Warp: 24; Weft 22
- Metric count: Warp: 28; Weft 28
Size: approx. 90 x 150 cm.
Colour: blue or green, but not khaki-green.
Colour quality must be able to withstand repeated washings and sterilizations.
All fabrics used must be suitable for normal washing - boiling and autoclaving- and be resistant to a 0.1% chlorine solution.
Instructions for use:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Supplied with: Manufacturer's instruction for use.
Packaging and labelling:
Unit presentation: 1 drape, non-sterile, multiple-use, size and manufacture's name.
Packaging: Protected in a plastic bag, single or multiple units.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark, lot number or batch number, UDI (if MDR followed), use-by-date, symbol for Medical device.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable.
Instruction for sterilization
Symbols used according ISO 15223
CE Mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class I device.
Environmental requirements:
ISO 14001
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc.
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Material: 100% cotton or 50% polyester - 50% cotton.
Reusable woven fabrics:
Fabric: 100% cotton.
- Weight per m²: 196 g/m²
- Number of threads per 3 cm: Warp: 75; Weft: 75
- Metric count: Warp: 28 / Weft: 27
or
Fabric: cretonne, cotton 100%:
- Number of threads/cm: warp: 24, weft: 24
- Metric count: warp: 28, weft: 28
- Weight per m²: 180g
or
Fabric : 50%polyesther-50% cotton fabric
- Weight per m²: +/- 175gr/m²
- Number of threads: Warp: 24; Weft 22
- Metric count: Warp: 28; Weft 28
Size: approx. 90 x 150 cm.
Colour: blue or green, but not khaki-green.
Colour quality must be able to withstand repeated washings and sterilizations.
All fabrics used must be suitable for normal washing - boiling and autoclaving- and be resistant to a 0.1% chlorine solution.
Instructions for use:
To cover patients on the operating table and to maintain aseptic conditions in the operation area.
Supplied with: Manufacturer's instruction for use.
Packaging and labelling:
Unit presentation: 1 drape, non-sterile, multiple-use, size and manufacture's name.
Packaging: Protected in a plastic bag, single or multiple units.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark, lot number or batch number, UDI (if MDR followed), use-by-date, symbol for Medical device.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable.
Instruction for sterilization
Symbols used according ISO 15223
CE Mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class I device.
Environmental requirements:
ISO 14001
free from heavy metals, substances of very high concern (SVHC), allergy-causing chemicals, azo dyes, formaldehyde etc.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $4.70 |
